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Also known as MenACWY-CRM197 (two doses)
MenACWY-CRM197 · 3 trials · 4 indications
To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM197 + Routine Vaccines (Non-Detailed) | EXPERIMENTAL | Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - infants who only provided SAEs (Serious Adverse Events) and medically attended AEs (Adverse Events). |
| Routine Vaccines (Non-Detailed) | ACTIVE_COMPARATOR | Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs. |
| MenACWY-CRM197 + Routine Vaccines (Detailed) | EXPERIMENTAL | Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs. |
| Routine Vaccines (Detailed) | ACTIVE_COMPARATOR | Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs. |
| MenACWY-CRM197 + Routine Vaccines (All) | EXPERIMENTAL | Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs. |
| Routine Vaccines (All) | ACTIVE_COMPARATOR | Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs. |
| MenACWY-CRM197 (2 doses) + Concomitant Vaccines | EXPERIMENTAL | Infants received two doses of MenACWY-CRM197 at 6 to 8 and 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months. |
| MenACWY-CRM197 (1 dose) + Concomitant Vaccines | EXPERIMENTAL | Infants received one dose of MenACWY-CRM197 at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age. |
| MenC (1 dose) + Concomitant Vaccines | ACTIVE_COMPARATOR | Infants received one dose of MenC vaccine at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age. |
| Adjuvanted MenACWY vaccine group | EXPERIMENTAL | Blood test |
| Non-adjuvanted MenACWY vaccine group | ACTIVE_COMPARATOR | Blood test |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM197 | BIOLOGICAL | Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age. |
| DTaP (Diptheria, Tetanus, Pertussis) Vaccine | BIOLOGICAL | Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age. |
| Hib (Haemophilus influenza b) Vaccine | BIOLOGICAL | Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age. |
| IPV (Inactivated Polio Vaccine) Vaccine | BIOLOGICAL | Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age. |
| Pneumococcal conjugate Vaccine | BIOLOGICAL | Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age. |
| MMR (Measles, Mumps, and Rubella) Vaccine | BIOLOGICAL | One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age. |
| Varicella Vaccine | BIOLOGICAL | One vaccination of Varicella vaccine was administered at 12 months of age. |
| Hepatitis A Virus | BIOLOGICAL | One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age. |
| MenACWY-CRM197 (two doses) | BIOLOGICAL | Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection. |
| MenC | BIOLOGICAL | One 0.5mL dose of MenC vaccine was administered by intramuscular injection. |
| PCV7 | BIOLOGICAL | One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection. |
| DTPa-IPV-HepB-Hib | BIOLOGICAL | One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection. |
| MenACWY-CRM197 (one dose) | BIOLOGICAL | One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection. |
| Blood test | BIOLOGICAL | Blood test, 40-months and 60-months children |
Inclusion Criteria: * healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg * for whom a parent/legal representative has given written informed consent after the nature of the stud...
MenACWY-CRM197 is an investigational meningococcal conjugate vaccine developed by Novartis AG (ticker NVS) for the prevention of meningitis and meningococcal disease. It is designed to protect against meningococcal serogroups A, C, W, and Y. The vaccine has been studied in Phase 3 clinical trials in infants, toddlers, and children.
MenACWY-CRM197 is being developed for the prevention of meningitis, meningococcal disease, and meningococcal meningitis caused by Neisseria meningitidis serogroups A, C, W, and Y. It is intended for use in healthy infants, toddlers, and children. The vaccine is investigational and has not been approved by the FDA.
MenACWY-CRM197 is being developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the clinical trials evaluating the vaccine in infants and children. The program includes a Phase 3 study that enrolled 7,744 participants, as well as smaller Phase 2 and Phase 3 studies.
MenACWY-CRM197 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 program includes a completed study of 7,744 healthy infants (NCT00806195) and a completed study of 662 infants and toddlers (NCT00667602).
MenACWY-CRM197 has been evaluated in completed clinical trials, including NCT00806195, a Phase 3 safety study of the vaccine given with routine infant vaccinations in 7,744 healthy infants across the United States, China, Costa Rica, Guatemala, Panama, and Peru. Other trials include NCT00667602 in Germany and NCT00601731 in Canada and the United Kingdom.
Yes, MenACWY-CRM197 (two doses) refers to the same Novartis vaccine candidate, MenACWY-CRM197. The parenthetical reflects study designs that evaluated one or two doses of the meningococcal ACWY conjugate vaccine in healthy infants and toddlers, such as the Phase 3 trial NCT00667602.